FDA.reportPublic FDA data

Centric Tray

Primary DI
07615208301304
Brand
Centric Tray
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
559166BN
Catalog number
559166BN
Device description
Centric Tray
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DIVO559166BN1PreviousHIBCC0
07615208301304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208301304076152083013047615208301304

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
448015938
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208592580IPS e.max Ceram Art7728287728282026-05-04
07615208592597IPS e.max Ceram Art7728297728292026-05-04
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07615208291643OptraGloss742102WW742102WW2026-04-23
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07615208539189IPS e.max Zirconia7642737642732026-03-26
07615208539677IPS e.max Zirconia7642817642812026-03-26
07615208539684IPS e.max Zirconia7642937642932026-03-26
07615208539691IPS e.max Zirconia7643017643012026-03-26
07615208539707IPS e.max Zirconia7643137643132026-03-26
07615208539714IPS e.max Zirconia7643217643212026-03-26
07615208539721IPS e.max Zirconia7643337643332026-03-26
07615208539738IPS e.max Zirconia7643417643412026-03-26
07615208539745IPS e.max Zirconia7643537643532026-03-26
07615208540055IPS e.max Zirconia7643617643612026-03-26
07615208540062IPS e.max Zirconia7643737643732026-03-26
07615208540079IPS e.max Zirconia7643817643812026-03-26
07615208540086IPS e.max Zirconia7643937643932026-03-26
07615208542301IPS e.max Zirconia7642747642742026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08961104622661Impression Tray SetMELPEX BEAUTY INSTRUMENTSEHY2026-05-21
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00190707193195Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
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00190707110826DuraLock®Ortho Organizers, Inc.EHY2025-09-25
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00190707110864DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110871DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110888DuraLock®Ortho Organizers, Inc.EHY2025-09-25
00190707110895DuraLock®Ortho Organizers, Inc.EHY2025-09-25
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07630392911948PRESIDENTDent4You AGEHY2024-11-22
07630392911955PRESIDENTDent4You AGEHY2024-11-22
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07630392911979PRESIDENTDent4You AGEHY2024-11-22
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07630392912006PRESIDENTDent4You AGEHY2024-11-22
07630392912013PRESIDENTDent4You AGEHY2024-11-22
07630392912020PRESIDENTDent4You AGEHY2024-11-22